Nigeria’s drug control agency, NAFDAC, has said that the Avastin 100mg injection, that allegedly led to the blindness of 10 patients at the National Eye Centre, Kaduna was wrongly administered.
According to a statement published on its official website on Sunday, Avastin was registered in Nigeria for cancer related ailments and its use at the eye centre “was an off-label use”.
Avastin is a drug used to treat age-related macular degeneration (AMD). It is also used to treat diabetic eye disease and other problems of the retina.
It is injected into the eye to help slow vision loss from these diseases.
The Nigerian Senate had earlier instructed the health agency to “suspend forthwith” the use of Avastine injections in the country.
The call for suspension was made after 10 persons went blind after the drug was reportedly adminstered on them.
The health agency said it received a complaint from a ‘concerned Nigerian’ on Monday, June 3, 2019 about the incident and immediately initiated an investigation.
It said officials then met and discussed with the management of the centre.
It also said a packet of Avastin injection in stock at the hospital was taken for laboratory analysis to ascertain the quality of the product.
The statement said an analysis, however, revealed that the Avastin injection conforms to quality specifications.
“The investigation established that the National Eye Centre, Kaduna used Avastin injection to treat patients with severe retina or macular pathologies and that the drug was administered on the 10 patients who were recalled by the Centre for observation and management following their complaints.
“The indications for which NAFDAC registered Avastin injection are metastatic colorectal cancer, metastatic breast cancer, advanced metastatic or recurrent non-small cell lung cancer, advanced and/ or metastatic renal cell cancer, ovarian cancer and cervical cancer.
“Therefore, the use of Avastin injection at the National Eye Center was an off-label use, i.e., it is not indicated on the label by the manufacturer or approved for treatment of eye ailments by NAFDAC.”
NAFDAC also implored health care providers to ensure the injection is used as indicated by the company and as registered by the agency “unless there is a future scientific review of the indication for the product”.